SYSTEM AND METHOD FOR THE REMOTE PROGRAMMING OF A PROGRAMMABLE PERSONAL MEDICAL DEVICE
The invention relates to a system and a method for the remote programming of a programmable personal medical device (10, 10′), in particular an implantable medical device such as a cardiac pacemaker, defibrillator, or the like, selecting (61) of a personal medical device, compiling (63) of a programming instruction (50) by accepting inputs of a user, and checking (63) the inputs for plausibility and compatibility with the personal medical device in a programming device (20), transmitting (65) the programming instruction to a patient intermediary device (30) tuned to the personal medical device via at least one indirect connection, receiving (67) of the programming instruction by the patient intermediary device, and transmitting of the programming instruction to the personal medical device, and accepting (69) of the programming instruction by a programmable controller of the personal medical device being provided.
The invention relates to a system for the remote programming of a programmable personal medical device, in particular an implantable medical device such as a cardiac pacemaker, defibrillator, or the like.
BACKGROUND OF THE INVENTIONTo ensure the most optimum possible care of the patient and optimum operation of a cardiac pacemaker or similar device, it is often necessary in practice to adapt the programming of the device on the basis of the course of the aftercare and the current constitution of the patient.
In some cases, a programming device is used for reprogramming the implant, which transmits an altered program for the implant directly into the implant via a typically wireless data communication. For this purpose, programming device and implant must be in a close spatial proximity to one another. This makes it necessary for the patient to visit his physician, a hospital, or another aftercare ward, i.e., a location at which the programming device is kept. The physician and patient must then necessarily be located at the same place at the same time. This necessity is often perceived as burdensome, and in particular it restricts the mobility of the patient.
The present invention may provide a system for the remote programming of a programmable personal medical device, in which a program transmission into the programmable personal medical device is possible without physician and patient having to meet. Additionally, the physician may retain the capability of using his familiar programming device.
The invention is based on the insight that a patient intermediary device, as is typically already used for transmitting telemetry data of a device such as a cardiac pacemaker to a service center, may be equipped with a further functionality of a relay station, to transmit a programming instruction prepared in a programming device into the personal medical device, without it being necessary for the wearer of the personal medical device to seek out the programming device. The patient intermediary device is located at a distance from the programming device in an area which is at least regularly sought out by the wearer of the personal medical device, so that the patient intermediary device may be used effectively as an intermediate station for the remote programming of the personal medical device.
Further advantageous designs of the invention are set forth in the claims and in the following description of the preferred exemplary embodiments.
The invention is explained in greater detail hereafter on the basis of preferred exemplary embodiments with reference to the appended figures. In the figures:
The implant 10 has a first interface 11 and a programmable controller 13. The implant 10 preferably additionally has an authentication unit.
The patient intermediary device 30 is equipped with a first interface 31 and a second interface 33. The patient intermediary device 30 preferably additionally has an authentication unit 37.
The programming device 20 has a first interface 21, a programming unit 23, and an input unit 25.
The input unit 25 is designed for the purpose of accepting inputs of a user, the input unit 25 being coupled to the programming unit 23 to prepare a programming instruction together with the programming unit 23. The programming unit 23 is implemented to generate a new or a revised program having a suitable set of control parameters for the personal medical device 10 on the basis of the inputs and to check this program for plausibility and compatibility with the personal medical device 10. Only a program which meets the particular desired requirements for plausibility and compatibility is permitted for a programming instruction.
The first interface 21 of the programming device 20 and in the second interface 33 of the patient intermediary device 30 are designed in the present case for a transmission of a data set 50 from the programming device 20 to the patient intermediary device 30. According to
The patient intermediary device 30 receives the data set 50, the authentication unit 37 checking the data set 50 for the presence of a valid authentication. The data set 50 having the programming instruction (see
The programming device 20 has a second interface 29 which is provided for producing a connection to the service center 40.
In the preparation and checking of a programming instruction, a query is directed to the service center via the interfaces 29 and 41, to transmit data stored in the data memory 43 in regard to the implant 10 to the programming device 20.
The programming instruction is prepared in a known manner using the data transmitted from the data memory 43.
The programming instruction which is embedded in the data set 50 is transmitted in accordance with the transmission as was described with reference to
In the present embodiment here, the implant 10 has a comparison unit 15. In the preparation of the programming instruction and the provision of the data from the data memory 43, an identification of a prior program of the implant 10 is generated, which is appended to the programming instruction in the data set 50. The comparison unit 15 is implemented to compare the identification appended to this programming instruction with the current program of the controller. If this comparison has the result that the programming instruction was not prepared on the basis of the current program active in the implant, the programming instruction is rejected. On the other hand, if the comparison shows that the current program, or a prior program corresponding to the current program, was the foundation of the programming instruction, the programming instruction is accepted and processed by the controller 13. Information on the comparison result for the acceptance or rejection of the programming instruction, respectively, is transmitted via the interfaces 11 and 31 to the patient intermediary device 30. This information may be stored here for a later query or transmitted directly to a suitable location for checking, for example.
The patient is equipped with an implant 10, which has a first interface 11, a controller 13, and a matching unit 15. The implant 10 corresponds to the implant shown in
The patient intermediary device 30 has a first interface 31, a second interface 33, a program memory 35, and an authentication unit 37. First and second interfaces 31, 33 and authentication unit 37 correspond to the units described above. The programming memory 35 is connected to the interface 33 and is used for the purpose of at least temporarily buffering a received data set and/or a received programming instruction. The buffered programming instruction and/or the buffered data set is relayed to the implant 10 at a suitable time via the interface 31. In this manner, it is possible for the patient intermediary device to receive a programming instruction and retain it until the patient having the implant 10 comes back into the communication range of the interface 31, so that even during an absence of the patient, the programming instruction may reach the patient intermediary device and be transmitted to the implant upon return of the patient and/or the implant to the patient intermediary device.
According to the embodiment shown in
The service center 40 receives a programming instruction which is embedded in a data set 50 via the interface 41. The received data set and/or the received programming instruction is analyzed by the data unit 47, predetermined data being added on the basis of the programming instruction to the data stored in the data memory 43, which may also be associated with the personal medical device. In this manner, for example, documentation of the programming instructions sent to the implant 10 may be retained in the data memory 43. The verification unit 49 is connected upstream from the data unit in the embodiment shown in
The programming device 20 has a first interface 21, a third interface 27, a programming unit 23, and an input unit 25. Programming unit 23 and input unit 25 are implemented for the purpose, similarly to the embodiment described in
The third interface 27 of the programming device 20 is designed to establish a connection to an implant 10′ located in close proximity and is used for transmitting a programming instruction prepared by the programming device 20 for the implant 10′ to the implant 10′. A data query may also be provided in the data memory 43 of the service center 40 in the way described above for the preparation of the programming instruction for the implant 10′. The programming device as shown in
Various embodiments of a system for the remote programming of an implant, for example, such as the embodiments shown in
The system according to the invention may also provide multiple programming devices, which are used in parallel or alternatively to one another.
In a further exemplary embodiment of the present invention, the programming device is linked to a hospital network via WLAN or wired LAN and has a connection to a home monitoring service center server (HMSC server) via the hospital network. The physician inputs his HMSC access data at the programming device, upon which the programming device presents the physician with a list of the patients who are assigned to the physician in the HMSC and are enabled for remote programming. After the selection of the appropriate patient and/or the appropriate implant, the last known program of the implant is displayed in the user interface familiar to the physician, the programming device being able to receive the last program from the HMSC or have it stored itself. After the revision and/or adaptation of the program, it is transmitted from the programming device to the HMSC and transmitted from there to the patient intermediary device of the appropriate patient. A unique program number of the old, i.e., still current programming is also sent. The new program on the basis of the transmitted programming instruction is only accepted in the implant when the program number stored and/or determined in the implant itself corresponds to the program number also transmitted.
According to a further alternative or supplementary aspect, the programming device is connected via a mobile wireless network, for example, by GSM, directly to the server of the HMSC, the sequence of the remote programming occurring as described above. As a further alternative and/or supplement, the programming device may be connected via a mobile wireless connection or the Internet directly to the patient intermediary device. In this case the detour via the server of the HMSC is dispensed with, the HMSC initially being dispensed with as the element of access control and documentation of the reprogramming. The HMSC may thus initially not provide any information about the current programming. However, it is possible that a further connection to the HMSC is established in parallel to the connection with the patient intermediary device, which may then be used, for example, for documentation of the reprogramming or a supplementary access check. In order that the programming device may connect directly to the patient intermediary device, the programming device requires an identification number, such as a telephone number of the patient intermediary device. The desired implant was preferably already programmed directly once previously using a programming device and set up for the remote programming together with the patient intermediary device, a password protection or another access control being able to be set up, for example.
An alternative sequence for asynchronous remote programming is schematically shown in
The preparation of the new program including the checking of all possible conflicts is performed in a way typical for a physician on the programming device as previously. Restrictions in the setting of the parameters (e.g., limiting of the setting range), which result from possible safety considerations in regard to the tele-transmission, are checked in the programming device. A valid parameter set for the tele-programming may, as an alternative to the transmission by close range telemetry, be transferred to a relay station for further distribution to the target implant. The programming device then transmits the program, for example, either directly to the patient intermediary device or via a web platform, for which it is equipped with a suitable network interface (e.g., WLAN, LAN, GSM, UMTS, Bluetooth). The transmission of the program may be performed asynchronously or synchronously. In synchronous transmission, a connection exists between the patient and his patient intermediary device during the program transmission from physician/programming device. The program transmission and possibly an acknowledgment occur immediately. In asynchronous transmission, the revised program is initially stored in the patient intermediary device and first transferred into the implant the next time the implant is in the communication range of the patient intermediary device. No chronological timing between physician and patient is necessary, however, it is initially not predetermined when the program will be active in the implant.
The remote programming preferably requires that the current program of the implant is known, i.e., the programming device may display the last known program to the physician, so that he may make his therapy decision on this basis and correctly. The remote transmission of the program additionally contains a method by which it is ensured that the new program is only accepted in the implant if the current implant program responds to the program expected by the programming device.
Claims
1. A system for the remote programming of a programmable personal medical device, in particular an implantable medical device such as a cardiac pacemaker, defibrillator, or the like, including:
- i. a programmable personal medical device (10, 10′),
- ii. a programming device (20) tuned to the personal medical device,
- iii. a patient intermediary device (30) tuned to the personal medical device,
- wherein:
- a. the personal medical device (10, 10′) includes: (1) a personal device first interface (11) allowing communication between the personal medical device (10, 10′) and the patient intermediary device (30),
- (2) a programmable controller (13) for controlling functions of the personal medical device (10, 10′) on the basis of control parameters, wherein the programmable controller (13) accepts programming instructions via the personal device first interface (11),
- b. the programming device (20) includes: (1) a programming device first interface (21) allowing communication between the programming device (20) and the patient intermediary device (30), (2) a programming unit (23): (a) accepting programming inputs for the personal medical device (10, 10′), the programming inputs including programming instructions for revising control parameters of the personal medical device (10, 10′), (b) checking the programming inputs for plausibility and compatibility with the personal medical device (10, 10′), (3) an input unit (25) for accepting user inputs, the input unit (25) being in communication with the programming unit (23) and cooperating therewith to transmit programming instructions via the programming device first interface (21) to the patient intermediary device (30),
- c. the patient intermediary device (30) includes: (1) an intermediary device first interface (31) allowing communication between the patient intermediary device (30) and the personal medical device (10, 10′), (2) an intermediary device second interface (33) allowing communication between the patient intermediary device (30) and the programming device (20), wherein the patient intermediary device (30) transmits programming instructions from the programming device (20) via the intermediary device second interface (33) to the personal medical device (10, 10′) via the intermediary device first interface (31).
2. The system of claim 1 wherein the personal medical device is an active medical implant.
3. The system of claim 2 wherein the personal medical device is an implantable cardiac pacemaker or defibrillator-cardioverter.
4. The system of claim 2 wherein the patient intermediary device first interface (31) and the personal device first interface (11) wirelessly communicate at a range of up to approximately 5 meters.
5. The system of claim 1:
- a. further including a service center (40) having: (1) a service center first interface (41) for connecting the service center (40) in communication with the programming device (20), and (2) a data memory (43) storing data associated with at least one personal medical device,
- b. wherein within the programming device (20): (1) the programming device first interface (21) allows communication between the programming device (20) and the intermediary device second interface (33), (2) the programming device (20) further includes a programming device second interface (29) allowing communication between the programming device (20) and the service center (40), (3) the programming unit (23) and the input unit (25) cooperate to request data associated with the personal medical device (10, 10′) from the service center (40).
6. The system of claim 5 wherein:
- a. the service center (40) has a service center second interface (45) allowing communications between the service center (40) and the patient intermediary device (30),
- b. the programming device (20) transmits the programming instructions to the service center (40), and
- c. the service center (40) transmits the received programming instructions to the patient intermediary device (30).
7. The system of claim 6 wherein the service center (40) has a data unit (47) which adds data, on the basis of the programming instructions, to the data associated with the personal medical device stored in the data memory (43).
8. The system of claim 5 wherein the service center (40) has a verification unit (49) which verifies the programming device (20) before transmission of
- a. data to the programming device (20), and/or
- b. the programming instructions.
9. The system of claim 1 wherein:
- a. the programming device (20) appends an identification (53) of a prior program to the programming instructions,
- b. the personal medical device (10, 10′) includes a comparison unit (15) which compares the identification appended to the programming instructions to the current program of the programmable controller (13),
- c. the programmable controller (13) rejects the programming instructions if comparison results are negative.
10. The system of claim 1 wherein the programmable controller (13) transmits a message to the patient intermediary device (30) and/or the programming device (20) upon one or more of:
- a. successful execution of the programming instructions, and/or
- b. denied execution of the programming instructions.
11. The system of claim 1 wherein the patient intermediary device (30):
- a. includes a program memory (35) for buffering the programming instructions, and
- b. transmits the programming instructions stored in the program memory (35) to the personal medical device (10, 10′) when a connection is established to the personal medical device (10, 10′).
12. The system of claim 1 wherein the programming device (20) has a third interface (27) for wireless communication with the personal medical device (10, 10′).
13. The system of claim 1 wherein:
- a. the programming device (20) appends an authentication (55) to the programming instructions, and
- b. the patient intermediary device (30) and/or the personal medical device (10, 10′) includes an authentication unit (37) which permits transmission of the programming instructions to the personal medical device (10, 10′) only if a valid authentication is present.
14. The system of claim 1 wherein:
- a. the programming unit (23) and input unit (25) cooperate to establish a transmission pathway for programming instructions,
- b. the programming unit (23) performs the check for plausibility and compatibility as a function of the established transmission pathway.
15. The system of claim 14 wherein the programming unit (23) only permits programming instructions having control parameters in a range which is narrower than a range which is provided for a direct transmission pathway from the programming device (20) to the personal medical device (10, 10′).
16. The system of claim 1 wherein the programming device (20), patient intermediary device (30), and programmable personal medical device (10, 10′) are all separate and spaced apart.
17. A system for the remote programming of a programmable personal medical device, in particular an implantable medical device such as a cardiac pacemaker, defibrillator, or the like, including:
- i. a programming device (20),
- ii. a patient intermediary device (30),
- iii. a programmable personal medical device (10, 10′), the programming device (20), patient intermediary device (30), and programmable personal medical device (10, 10′) being spaced from each other, wherein:
- a. the programming device (20) includes: (1) a programming unit (23) accepting input of programming instructions for the programmable personal medical device (10, 10′); (2) a programming device first interface (21) in communication with the patient intermediary device (30) and transmitting the programming instructions thereto;
- b. the patient intermediary device (30) includes: (1) an intermediary device second interface (33) receiving the programming instructions from the programming device (20), (2) an intermediary device first interface (31) transmitting the programming instructions to the personal medical device (10, 10′),
- c. the personal medical device (10, 10′) includes: (1) a personal device first interface (11) receiving the programming instructions from the intermediary device first interface (31), (2) a programmable controller (13) for controlling functions of the personal medical device (10, 10′) in accordance with the programming instructions received by the personal device first interface (11).
18. The system of claim 16 wherein the programming device first interface (21) transmits the programming instructions to the patient intermediary device (30) via a service center (40), the service center (40) including:
- a. a service center first interface (41) receiving the programming instructions from the programming device first interface (21), and
- b. a service center second interface (45) transmitting the programming instructions to the intermediary device second interface (33).
19. A system for the remote programming of a programmable personal medical device, in particular an implantable medical device such as a cardiac pacemaker, defibrillator, or the like, including:
- i. a programming device (20),
- ii. a service center (40)
- iii. a patient intermediary device (30),
- iv. a programmable personal medical device (10, 10′),
- wherein:
- a. the programming device (20) accepts input of programming instructions for the programmable personal medical device (10, 10′), and thereafter transmits the programming instructions;
- b. the service center (40) receives the programming instructions from the programming device (20), and thereafter transmits the programming instructions;
- c. the patient intermediary device (30) receives the programming instructions from at least one of: (1) the service center (40), and (2) the programming device (20), and thereafter transmits the programming instructions to the personal medical device (10, 10′),
- d. the personal medical device (10, 10′) includes a programmable controller (13) for controlling functions of the personal medical device (10, 10′) in accordance with the programming instructions received from the patient intermediary device (30).
Type: Application
Filed: Jul 1, 2008
Publication Date: Jan 22, 2009
Patent Grant number: 8423149
Inventor: Carsten Hennig (Berlin)
Application Number: 12/165,733
International Classification: A61N 1/08 (20060101);